NCT04221477

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in participants with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Obinutuzumab	Obinutuzumab will be administered by IV infusion at a dose of 1000 mg at Baseline and Weeks 2, 24, 26, 50 (group 2: placebo), and 52 and subsequently from Week 80 and every 6 months thereafter, based on response.
DRUG	MMF	MMF willl be administered at a target dose of 2.0 - 2.5 g/day in divided doses through Week 80.
DRUG	Prednisone	Prednisone 0.5 mg/kg/day (maximum 60 mg/day) will be started on Day 2. Beginning on Day 15, prednisone will be tapered to 5 mg/day and continued until Week 80.
DRUG	Placebo	Placebo matching obinutuzumab will be administered by IV infusion at baseline and Weeks 0, 2, 24, 26, 50 and 52 and subsequently from Week 80 and every 6 months thereafter based on response.
DRUG	Methylprednisolone	Methylprednisolone 80 mg IV will be administered as predmedication prior to infusions.
DRUG	Acetaminophen	Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
DRUG	Diphenhydramine	Diphenhydramine 50 mg will be administered as premedication prior to infusions.

Timeline

• Start date: 2020-08-10
• Primary completion: 2024-08-15
• Completion: 2031-02-28
• First posted: 2020-01-09
• Last updated: 2026-02-06
• Results posted: 2025-11-06

Locations

74 sites across 15 countries: United States, Argentina, Brazil, Colombia, France, Germany, Israel, Italy, Mexico, Peru, Poland, Russia, South Africa, Spain, United Kingdom

Regulatory

• FDA-regulated drug study